APPLICATION
ANDA220335
TYPE
ANDA
ORIGINAL APPROVAL
2026-02-25
LATEST ACTION
2026-02-25
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CETIRIZINE HYDROCHLORIDEPrescription
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-02-25UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.